Securement device

ABSTRACT

A securement device holds a medical article having flexible portions in position upon the body of a patient and inhibits movement of the medical article. The medical article may be insertable into the securement device from above, from below, or along a longitudinal axis of the device. The securement device may have abutment surfaces which interact with the flexible portions of the medical article to further inhibit rotation of the device.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a securement system used to attach a medicalarticle to a patient.

2. Description of the Related Art

It is common in the treatment of patients to utilize catheters tointroduce fluids and medications directly into the patient or towithdraw fluids from the patient. Often, it becomes desirable tomaintain such catheterization over an extended period of time during thetreatment of a patient. In order to keep the catheter or other medicalarticle properly positioned for the duration of treatment, the catheteror medical article can be secured to the patient in a variety of ways.Most commonly, this involves taping or suturing the catheter or medicalarticle to the patient.

Securing a catheter with tape upon the patient traditionally has certaindrawbacks. The use of tape at the insertion site can retain dirt orother contaminant particles, potentially leading to infection of thepatient. Tape also fails to limit catheter motion and, therefore,contributes to motion related complications like phlebitis, infiltrationand catheter migration. Additionally, removal of taped dressings canitself cause undesired motion of the catheter upon the patient.

Taped dressings also require periodic changes. The frequent, oftendaily, removal and reapplication of adhesive tape to the skin of thepatient can excoriate the skin. Such repeated applications of tape overthe catheter or medical article can additionally lead to the build up ofadhesive residue on the outer surface of the catheter or medicalarticle. This residue can result in contaminants adhering to the medicalarticle itself, increasing the likelihood of infection of the insertionsite. This residue can also make the catheter or medical articlestickier and more difficult to handle for healthcare providers.

Suturing also carries risk, both to healthcare workers and patients.Healthcare workers can suffer accidental needlestick injury, which mayexpose them to hepatitis, HIV, and other pathogens. Patients can sufferlocal or even systemic infection from suture, as well as scarring andpain.

Portions of certain medical articles, such as catheters, may comprisesoft, flexible material, complicating securement of these articles. Theflexibility of components of these medical articles can lead to flexureor motion of a secured medical article relative to the insertion site.An improved system that provides secure mechanical fixation of suchmedical articles without unnecessary manipulation of the medical articleafter insertion and without undesirable flexure or motion relative to aninsertion site is desired for securement of such catheters and othermedical articles.

SUMMARY OF THE INVENTION

In one embodiment, a securement device for securing a medical article isprovided, the securement device including first and second anchor pads,each including an upper foam layer and a lower adhesive surface, thelower adhesive surface being configured to attach to an epidermal layerof a patient, and a retainer including, a body member having an invertedchannel formed therethrough, the inverted channel being configured toretain a portion of the medical article and having a longitudinal accessopening disposed on an underside of the body member to allow ingress andegress of the portion of the medical article, first and second anchorpads underlying the body member and laterally offset in oppositedirections from the longitudinal access opening, first and secondproximal members extending generally transversely downward from the bodymember and defining a proximal retention surface therebetween, where thefirst proximal member terminates in a first proximal footing which issecured to the first anchor pad and the second proximal memberterminates in a second proximal footing secured to the second anchorpad, first and second distal members extending generally transverselydownward from the body member and defining a distal retention surfacetherebetween, where the first proximal member terminates in a firstdistal footing which is secured to the first anchor pad, and where thesecond proximal member terminates in a free end unsecured to an anchorpad, and an offset member extending laterally outward and longitudinallyproximal from a point on the body member, the offset member having adownwardly extending portion at its outer end, the downwardly extendingportion terminating in a second distal footing which is secured to thefirst anchor pad.

In another embodiment, a system for securing a medical article isprovided, the system including a retainer, the retainer including aproximal pair of upwardly extending members defining a proximalretention surface therebetween, first and second raised proximalportions extending along a proximal edge of the retainer, a distal pairof upwardly extending members defining a distal retention surfacetherebetween, first and second raised distal portions extending along adistal edge, and a medical article, the medical article including alongitudinally extending central body, a pair of laterally extendingwings extending outward from the central body, and an outwardlyextending member extending laterally outward and longitudinally distalfrom the central body, at least a portion of the central body beingretained by the proximal and distal retention surfaces of the retainer.

In another embodiment, a retainer for securing a medical article, theretainer including a base having an upper surface tilted at a downwardangle in a proximal direction, the base comprising a longitudinallyextending depression formed therein. The retainer further includes aretention structure. The retention structure includes a substantiallycylindrical channel extending between proximal and distal ends, a firstportion of the channel being movable in a generally transverse directionrelative to a second portion of the channel.

In another embodiment, a securement device is provided for receiving amedical article having an elongated body, a pair of wings, and a sidelumen, the side lumen extending through at least a portion of one of thepair of wings, the securement device including a body member having afirst pair of footings, a second pair of footings, and an arm member,each of the first and second pairs of footings defining a retentionsurface for receiving a portion of the elongated body of the medicalarticle therebetween, at least one of the first pair of footings and atleast one of the second pair of footings defining a side opening in thebody member, the side opening receiving at least a portion of one of thepair of wings and at least a portion of the side lumen when the medicalarticle is secured within the body member, the arm member defining aside channel at least partially aligned with the side opening, the sidechannel receiving at least a portion of the side lumen when the medicalarticle is secured within the body member, and at least one anchor padsupporting the body member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a securement device having a medicalarticle retained therein in accordance with a preferred embodiment ofthe present invention.

FIG. 2 is a perspective view of the medical article removed from thesecurement device of FIG. 1.

FIG. 3 is a perspective view of the securement device of FIG. 1 withoutthe medical article.

FIG. 4 is a top plan view of the securement device of FIG. 3.

FIG. 5 is an exploded assembly view of the medical article of FIG. 2aligned with the securement device of FIG. 3.

FIG. 6 is a perspective view of the anchor pad from the securementdevice of FIG. 3.

FIG. 7 is a top plan view of the retainer from the securement device ofFIG. 3.

FIG. 8 is a bottom plan view of the retainer of FIG. 7.

FIG. 9 is a front view of the retainer of FIG. 7.

FIG. 10 is a back view of the retainer of FIG. 7.

FIG. 11 is a right side view of the retainer of FIG. 7.

FIG. 12 is a left side view of the retainer of FIG. 7.

FIG. 13 is a cross-section view of the retainer taken along line 13-13in FIG. 7.

FIG. 14 is a cross-section view of the retainer taken along line 14-14in FIG. 7.

FIG. 15 is a perspective view of the securement device of FIG. 3 withthe medical article of FIG. 2 retained therein.

FIG. 16 is a top plan view of the securement device and medical articleof FIG. 15.

FIG. 17 is a side cross-section of the securement device and medicalarticle taken along line 17-17 in FIG. 16.

FIG. 18 is a perspective view of another embodiment of a securementdevice for receiving the medical article from FIG. 2.

FIG. 19 is a perspective view of the securement device of FIG. 18without the medical article.

FIG. 20 is a perspective view of the anchor pad from the securementdevice of FIG. 19.

FIG. 21 is a top plan view of the securement device of FIG. 19.

FIG. 22 is a front view of the retainer of the securement device takenalong line 22-22 in FIG. 21 without the anchor pad.

FIG. 23 is a back view of the retainer of the securement device takenalong line 23-23 in FIG. 21 without the anchor pad.

FIG. 24 is a right side view of the retainer of the securement devicetaken along line 24-24 in FIG. 21 without the anchor pad.

FIG. 25 is a right side view of the retainer of the securement devicetaken along line 25-25 in FIG. 21 without the anchor pad.

FIG. 26 is a cross-section view of the retainer taken along line 26-26in FIG. 21 without the anchor pad.

FIG. 27 is a cross-section view of the retainer taken along line 27-27in FIG. 21 without the anchor pad.

FIG. 28 is an exploded assembly view of the securement device andmedical article of FIG. 18.

FIG. 29 is a top plan view of the securement device of FIG. 18 with themedical article retained therein.

FIG. 30 is a cross-section view of the retainer taken along line 30-30in FIG. 29 without the anchor pad.

FIG. 31 is a perspective view of another embodiment of a securementdevice for receiving the medical article from FIG. 2.

FIG. 32 is a top plan view of the securement device and retained medicalarticle of FIG. 31.

FIG. 33 is the same view as FIG. 32 except with the medical articleremoved.

FIG. 34 is a perspective view of the securement device of FIG. 33.

FIG. 35 is a perspective view of the anchor pad from FIG. 34.

FIG. 36 is a front view of the retainer taken along line 36-36 in FIG.33 without the anchor pad.

FIG. 37 is a back view of the retainer taken along line 37-37 in FIG. 33without the anchor pad.

FIG. 38 is a side view of the retainer taken along line 38-38 in FIG. 33without the anchor pad.

FIG. 39 is a side view of the retainer taken along line 39-39 in FIG. 33without the anchor pad.

FIG. 40 is a cross-section of the retainer taken along line 40-40 inFIG. 33 without the anchor pad.

FIG. 41 is a cross-section of the retainer taken along line 41-41 inFIG. 33 without the anchor pad.

FIG. 42 is an exploded assembly view of the securement device andmedical article of FIG. 31.

FIG. 43 is a side cross-section of the securement device and retainedmedical article of FIG. 32, taken along the longitudinal axis of thesecurement device and shows a tang of a biased flap engaged with arecess in the medical article.

FIG. 44 is the same view as FIG. 43 except that the tang has been liftedaway from the medical article to disengage the medical article from theretainer.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description and the accompanying figures, which describeand show the preferred embodiments, are made to demonstrate severalpossible configurations that a securement system can take to includevarious aspects and features the invention. Those of skill in the artwill recognize that the disclosed aspects and features of the inventionare not limited to any particular embodiment of a securement system, andsecurement systems, which include one or more of the inventive aspectsand features herein described, can be designed for use with a variety ofmedical articles.

To assist in the description of these components of the securementsystem, the following coordinate terms are used (see FIG. 1). A“longitudinal axis” is generally parallel to a portion of the medicalarticle retained by the securement system, as well as parallel to theaxis of a channel of the retainer, through which the medical articleextends. A “lateral axis” is normal to the longitudinal axis. A“transverse axis” extends normal to both the longitudinal and lateralaxes. In addition, as used herein, “the longitudinal direction” refersto a direction substantially parallel to the longitudinal axis; “thelateral direction” refers to a direction substantially parallel to thelateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. The term “axial” as usedherein refers to the axis of the channel or connector fitting, andtherefore is substantially synonymous with the term “longitudinal” asused herein.

Also, the terms “proximal” and “distal”, which are used to describe thepresent securement system, are used consistently with the description ofthe exemplary applications (i.e., the illustrative examples of the useapplications). Thus, proximal and distal are used in reference to thecenter of the patient's body. The terms “upper,” “lower,” “top,”“bottom,” “underside,” “upperside” and the like, which also are used todescribe the present securement system, are used in reference to theillustrated orientation of the embodiment. For example, the term“upperside” is used to describe the portion of the retainer that islocated above a lateral axis that passes through the axis of thechannel. The term “underside” is used to describe the portion of theretainer that is located below a lateral axis that passes through theaxis of the channel. Brief introductions to some of the features, whichare common to the described embodiments of the securement systems, arenow described. In the illustrated embodiment, the arrows on thesecurement device point in the direction toward the insertion site(i.e., in the proximal direction).

The preferred embodiments of the present invention advantageouslyprovide a medical line securement system for securing a medical articleto a patient. The medical article preferably has an elongated body andlaterally extending wings. The elongated body and laterally extendingwings cooperate with a retainer to arrest movement of the medicalarticle in longitudinal, lateral, and transverse directions when placedwithin the retainer.

In certain of the embodiments described below, the retainer has a bodymember which includes an inverted channel formed therethrough. Theinverted channel has a longitudinal access opening located on anunderside of the retainer to allow ingress or egress of the medicalarticle. The medical article is installed or removed from the undersideof the retainer via this access opening. The access opening may beasymmetrical about the longitudinal axis of the securement device tofacilitate entry of an asymmetrical medical article. Such an arrangementallows the medical provider to align at least a portion of the medicalarticle with the retainer prior to fixing the retainer to the patient'sskin. In this way, the inverted channel retains a portion of the medicalarticle. In other embodiments described below, the retainer has a bodymember including a non-inverted channel formed therethrough. In suchembodiments, the medical article may be installed or removed from theupper side of the medical article, such that the retainer is disposedbetween the medical article and the patient's skin. In this embodiment,the medical article may be installed or removed after fixing theretainer to the patient's skin. In further embodiments, the medicalarticle may be inserted generally along the longitudinal axis of thesecurement device.

The retainer of each embodiment described below further includes atleast one support that is preferably disposed on the underside of theretainer at a position lower than the access opening. With thisconstruction, the retainer holds the retained portion of medical articleaway from the patient's skin, when the retained portion is positionedwithin the retainer channel, to avoid chaffing or excoriating the skin.The support in certain of the illustrated embodiments includes mountingfeet that are integral with the body member and are attached to left andright anchor pads. The lower surfaces of the left and right anchor padsattach to the patient's skin.

To facilitate a complete understanding of the embodiments, the remainderof the detailed description describes the securement system withreference to the figures, wherein like elements among the embodimentsare referenced with like numerals throughout the following description.

FIG. 1 is a perspective view of a securement device 100 configured inaccordance with an embodiment of the present invention, and secured tothe skin 10 of a patient. In the illustrated embodiment, the securementdevice comprises a retainer portion 120 attached to a left anchor pad110 and a right anchor pad 112. The left and right anchor pads 110, 112are adhered to the skin 10 of the patient.

The securement device 100 in FIG. 1 is shown having a medical article 20retained therein. FIG. 2 is a perspective view of the medical article 20retained in the securement device of FIG. 1. The medical article 20comprises a catheter having wings 40 a and 40 b extending laterallyoutward from the central axis 22 of the catheter. In certainembodiments, these laterally extending wings may comprise a flexiblematerial or a combination of a flexible material with a less flexiblespine. The spine may be disposed on the surface of the wings or embeddedwithin the wings.

The medical article 20 further includes a longitudinally extendingcentral body 30, a longitudinally extending tip 34 at the proximal endof the medical article, and a distal end 38 which may include connectionfeatures for additional devices or structures, such as a needle grip andpush tab assembly (not shown). Suitable materials for the body 30include, but are not limited to, thermoplastic resins such asfluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE),polyurethane and the like. The body 30 may comprise a material that isless flexible than the wings 40 a, 40 b.

The medical article includes a first substantially cylindrical section32 located at or near the proximal end of the central body 30, and asecond substantially cylindrical section 36 located at or near thedistal end of the central body 30. Although described as substantiallycylindrical, the diameter of these first and second sections 32 and 36may vary somewhat over the length of the substantially cylindricalsections. A linear variation in the diameter of these sections willresult in the section having a frustroconical shape, and a non-linearvariation in the diameter of these sections will result in the sectionhaving a curved profile.

The medical article 20 further includes section 50 which extendslaterally outward and longitudinally back in a distal direction from aportion of the central body 30. In the illustrated embodiment, theoutwardly extending portion 50 forms roughly a 45 degree angle with thecentral body 30, although other embodiments of medical articles 20 mayinclude an outwardly extending portion that is oriented at a differentangle, including extension transversely upward or downward from thecentral body 30. This outwardly extending portion may provide a luminalpath between the tip of the catheter and tubing 52 connected to theproximal end of the outwardly extending portion 50. Because theoutwardly extending portion is oriented at an angle to the central axis22 of the medical article 20, the bend in the luminal path allowsinsertion of a needle along the central axis 22 of the medical article20, such as from the distal end 38 of the medical article 20.

Examples of such medical articles in which portions of the medicalarticle comprise a flexible material include the commercially availableBD NEXIVA™ flexible winged catheters, which include flexible wingstructures. Because a large portion of the medical article 20 comprisesa flexible material, mechanical fixation between a securement device andthe flexible portions of the medical article 20 may be difficult due tothe possible deformation of the flexible portions of the medical article20 and resulting movement of the catheter tip 34.

FIG. 3 is a perspective view of the securement device 100 of FIG. 1, andFIG. 4 is a top plan view of the same. As shown in FIGS. 1, 3, and 4,the illustrated securement device 100 comprises three main components:two anchor pads 110, 112, and a retainer 120. The illustrated retainer120 includes four footings: a front left footing 210, a front rightfooting 212, a back left footing 214, and a back right footing 216. Eachof the left footings 210 and 214 is disposed upon the left anchor pad110, and each of the right footings 212 and 216 is disposed upon theright anchor pad 112. Each of the footings 210, 212, 214, and 216 islaterally offset from a central or longitudinal axis 202 of the retainer120. The retainer 120 further includes a central body 204 supported bythe footings 210, 212, 216, and 218 and extending generally about thecentral axis 202 of the retainer. The central body 204 includes a frontor proximal portion 206 and a back or distal portion 208.

FIG. 5 is an exploded assembly view of the securement device 100 ofFIGS. 1, 3, and 4 in which the retainer 120 is aligned with the medicalarticle 20 to be retained therein. For the purposes of illustration, theretainer 120 is shown as detached from the anchor pads 110 and 112,although in practice, the securement device will typically be providedwith the retainer 120 secured to the anchor pads 110 and 112. As notedabove, the securement device 100 can form a component of acatheterization or securement system that also includes one or moremedical articles, such as connector fittings, catheters, hubs, catheteradaptors, fluid supply lines, or other articles suitable for securementvia the anchor pads and retainer. It can be seen that the interior edgesof the anchor pads facing one another define an opening which permitsthe wings 40 a and 40 b of the medical article to pass upwardlytherethrough. The securement device 100 thus permits a medical articlesuch as medical article 20 to be brought upward from beneath the medicalarticle through the space between the anchor pads 110 and 112 to contactthe retainer 120. The retainer 120 is generally dimensioned such thatthe first substantially cylindrical section 32 of the medical article 20can be brought into contact with the front portion 206 of the retainer120 while the second substantially cylindrical section 36 of the medicalarticle 20 can be brought into contact with the back portion 208 of theretainer 120.

After the medical article 20 is secured within the retainer 120, theanchor pads 110, 112 are then secured to the skin of the patient,generally by an adhesive disposed upon the bottom surface of the pads.In this way, the retainer 120 secures the medical article to thepatient. Thus, the retainer 120 at least restricts, if not prevents,lateral and transverse movement of the retained section of the medicalarticle. Additional features of the securement device 100 can restrict,if not prevent, longitudinal and rotational movement of the retainedsection of the medical article. The embodiment illustrated is preferablyfor use with a medical article as described with reference to FIG. 2.The embodiments of the anchor pad and the retainer are described in moredetail below.

FIG. 6 illustrates the anchor pads 110 and 112, respectively, apart fromthe rest of the securement device 100. Each of anchor pads 110 and 112comprise a generally scalloped region 120 a, 120 b located at theinterior forward corner of each anchor pad. The scalloped configurationeases the process of aligning the securement device 100 with a catheterinsertion site in the patient's skin. Anchor pads 110 and 112 alsocomprise a substantially triangular cutout 122 a or 122 b on theirinterior edges to permit passage of portions of medical devices such asflexible wings 40 a and 40 b. Right anchor pad 112 further comprises anangled edge 124 at the distal interior corner of anchor pad 112 topermit the passage of outwardly extending portion 50 of medical device20 and the connected tubing 52. Thus, the anchor pads 110 and 112 aresized and dimensioned so that a medical article 20 can pass between themin a generally transversely upward direction. Although only a singleshape of the anchor pad is illustrated in FIG. 6, those of skill in theart will recognize that a variety of shapes can be used. For example,the interior cutouts may comprise different sizes or shapes toaccommodate a variety of medical articles.

Each anchor pad 110, 112 desirably comprises a laminate structure withan upper plastic (e.g., Tricot woven polyester), paper or foam layer(e.g. closed-cell polyethylene foam) and a lower adhesive layer. Thelower adhesive layer constitutes a lower surface 160 of the anchor pad.The lower surface 160 desirably is a medical-grade adhesive and can beeither diaphoretic or nondiaphoretic, depending upon the particularapplication. Such foam with an adhesive layer is available commerciallyfrom Avery Dennison of Painsville. Ohio. While not illustrated, theanchor pads 110, 112 can include suture holes in addition to theadhesive layer to further secure the anchor pad to the patient's skin.

In other variations, a hydrocolloid adhesive or zinc oxide-basedadhesive can advantageously be used upon the anchor pads 110, 112 forattaching the anchor pads to the skin of the patient. The hydrocolloidor zinc oxide-based adhesive can be used either alone or in combinationwith another medical grade adhesive (e.g. in combination with theadhesive available from Avery Dennison). Hydrocolloid and zincoxide-based adhesives have less of a tendency to excoriate the skin of apatient when removed. This can be particularly important for patientswhose skin is more sensitive or fragile, such as neonates and those witha collagen deficiency or other skin related condition.

In another variation, each anchor pad 110, 112 comprises a laminatestructure with an upper woven layer and a lower adhesive layer. Theupper layer can be polyester or other suitable polymer or textilematerials. One particular suitable material is woven polyester availablecommercially under the name “Tricot” from Tyco. The lower adhesive layerconstitutes the lower surface 160 of the anchor pad. The lower surfacedesirably is a medical-grade adhesive and can be either diaphoretic ornondiaphoretic, depending upon the particular application.

A surface of the upper foam layer constitutes an upper surface 170 ofthe anchor pads 110, 112. The upper surface 170 can be roughened bycorona-treating the foam with a low electric charge. The roughened orporous upper surface can improve the quality of the adhesive joint(which is described below) between the footings 210, 212, 216, and 218and the anchor pads 110, 112. In a further variation, the flexibleanchor pad can comprise an upper paper or other woven or nonwoven clothor plastic layer in lieu of a roughened upper foam surface.

As illustrated in FIG. 6, removable release liners 130 a and 130 bdesirably cover the adhesive lower surface 160 before use. The releaseliners 130 a and 130 b may comprise paper, plastic, or any othersuitable material. The liners 130 a and 130 b preferably resist tearingand desirably are divided into a plurality of pieces to ease attachmentof the pad to a patient's skin.

The liners 130 a and 130 b comprises folded over portions to define pulltabs 132. The pull tabs 132 can be utilized to remove the release liners130 a and 130 b from their adhesive lower surface 160 duringapplication. A healthcare provider uses the pull tab 132 by grasping andpulling on it so that the liners 130 a and 130 b are separated from thelower surfaces 160 of anchor pads 110 and 112. The pull tabs 132overcomes any requirement that the healthcare provider pick at a corneredge or other segment of the liner in order to separate the liner fromthe adhesive layer.

The pull tabs 132 can be designed in a variety of configurations. Forexample, the pull tab 132 can be located along a center line of theanchor pads 110 and 112; or alternatively, the pull tab can be locatedalong any line of the anchor pads 110 and 112 in order to ease theapplication of the anchor pad onto the patient's skin at a specificsite. In certain embodiments, the pull tabs may extend in a generallylongitudinal direction as shown, facilitating grasping of the pull tabsfrom the back side of the retainer, although the pull tabs may in otherembodiments be oriented in a lateral direction, or at any appropriateangle.

It can also be seen that the liners 130 a and 130 b may be dimensionedto substantially match the shape of the anchor pads 110 and 112,particularly the interior sides 122 a and 122 b of the anchor pads 110and 112, including the angled edge 124 at the proximal interior cornerof anchor pad 112. In this way, the medical device 20 can be insertedinto the retainer 120 before removal of the liners 130 a and 130 b,without interference from the liners 130 a and 130 b.

An embodiment of the retainer 120 is described with reference to FIGS.7-14, which illustrate only the retainer 120, detached from the anchorpads. FIG. 7 is a top plan view of the retainer 120 which inhibits atleast motion of an installed medical article. In certain embodiments,the retainer 120 arrests movement in the longitudinal, lateral andtransverse directions. FIG. 8 is a bottom plan view of the retainer 120.

It can be seen in FIG. 8 that the central body 204 defines an invertedcentral channel 222 extending along a longitudinal axis 202 of theretainer 120. The front portion 206 of the central body 204 of theretainer 120 comprises a front interior abutment surface 226 locatedgenerally laterally between the front left footing 210 and the frontright footing 212, and centered along a longitudinal axis 202 of theretainer. Similarly, the back portion 208 of the central body 204 of theretainer 120 comprises a back interior abutment surface 228 laterallyoffset from the back left footing 214 and centered along thelongitudinal axis 202 of the retainer. The central body 204 of theretainer further comprises a longitudinally extending aperture 224substantially aligned with the longitudinal axis of the retainer, whichmay facilitate alignment of the retainer 120 with the medical article tobe retained during the fixation process, and allow a clear view of theretained catheter or other medical article once the retained medicalarticle is in place on the patient's skin.

FIG. 9 is a front view of the retainer 120, illustrating thecross-sectional shape of the central channel 222 at the front of theretainer. The shape of the central channel 222 is defined at the frontportion 206 of the retainer 120 by front interior abutment surface 226,which in the illustrated embodiment extends more than 180 degrees aboutthe longitudinal axis 202 of the retainer 120, such that the lowermostportions of front abutment surface 226 are formed by inwardly extendingportions 232 a and 232 b of the retainer, spaced apart from one anotherat their closest point by a distance which is smaller than the diameterof the overlying section of central channel 222. The difference in widthbetween the diameter of the channel 222 and the distance between theinwardly extending portions 232 a and 232 b of the retainer allows theretainer to form a snap-fit connection with the retained medicalarticle, such that one or both of the retainer and the medical articlecan be slightly deformed to allow the metrical article to be pressedinto the central channel 222, and the inwardly extending portions 232 aand 232 b can then prevent unintentional transverse movement of themedical article in a downward direction.

Similarly, FIG. 10 is a back view of the retainer 120, illustrating thecross-sectional shape of the central channel 222 at the back of theretainer. The rear interior abutment surface 228 defines the shape ofthe central channel at the back portion 208 of the retainer 120. Therear interior abutment surface 228 also extends more than 180 degreesabout the longitudinal axis 202 of the retainer 120, and the lowermostportions of rear abutment surface 228 are formed by inwardly extendingportions 232 c and 232 d of the retainer. The rear abutment surfacetherefore also provides a snap-fit connection with the retained medicalarticle.

It can be seen that of the two inwardly extending surfaces 232 c and 232d which form a portion of rear abutment surface 228, left surface 232 cextends inwardly from a sidewall 242 extending between the rear portion208 of central body 204 and left rear footing 214. In contrast, rightsurface 232 d extends inwardly from a downwardly extending portion 260of the retainer 120 which is not secured at its base to a footing, butis connected only at its top to overlying arm 250 which extends outwardfrom the central body 204 of the retainer. Because the downwardlyextending portion 260 is not attached at its base to a footing, thedownwardly extending portion 260 may be substantially thicker than thesidewall 242, in order to provide sufficient rigidity and support torear abutment surface 228 to maintain the snap-fit connection when amedical article is secured therein.

Inner surface contours of portions of the central channel 222 preferablyare selected depending on the geometry of the portion of the medicalarticle to be retained. In particular, either of the front abutmentsurface 226 and rear abutment surface 228 may be configured to providechannel sections with a substantially constant radius along theirlengths when the portion of the medical article to be retained has aconstant diameter. In other embodiments, when the portion of the medicalarticle to be retained comprises a varying radius, such as afrustroconical shape, the radius of the portion of the central channel222 defined by one of the abutment surfaces may similarly comprise avarying radius. In the illustrated embodiment, the front and rearabutment surfaces comprise a slight taper, as can best be seen in FIGS.8 and 10. It can also be seen that the portion of the central channel222 located between the abutment surfaces 226 and 228 may comprise awidening portion, and in certain embodiments may not serve a retentionfunction. Additional embodiments of the central channel 222 of theretainer can comprise a plurality of different radii and/or taperingregions. By matching the inner surface contour of portions of thecentral channel 222 to the outer surface of the secured portion of amedical article, a more effective securement may be achieved.

FIG. 11 is a left side view of the retainer 120, and FIG. 12 is a rightside view of the retainer 120. As can best be seen in FIGS. 10 and 12,the outwardly extending arm 250 of the retainer 120 cooperates withsidewall 244 and downwardly extending portion 260 to define a passage256 which accommodates the outwardly extending portion 50 and tubing 52of medical article 20 (see FIG. 2). In the illustrated embodiment, thepassage 256 is substantially larger than the cross-sectional size of theoutwardly extending portion 50 and tubing 52 of the medical article 20,such that the outwardly extending portion 50 and/or tubing 52 can extendthrough the passage without contacting the interior surface 258 of thepassage 256. It can also be seen that the facing surfaces of thesidewall 244 and the downwardly extending portion 260 may besubstantially parallel to one another, and may also be substantiallyparallel to the direction in which the outwardly extending portion 50 ofmedical device 20 will extend when the medical device is secured withinthe retainer 50. Such an arrangement may reduce the length of arm 250 ofthe retainer.

It can also be seen in FIG. 11 that the right side of central body 204of the retainer 120 comprises a scalloped cutout 274 on the underside ofcentral body 204, to enable the outwardly extending portion 50 of themedical article to pass through. The difference between the height ofthe scalloped cutout 274 and the height of the lower right edge 272 b ofthe central body 204 may vary based on the particular design of themedical article to be retained.

In the illustrated embodiment, the medical article 20 to be retainedcomprises a central body 30 having an upper surface which is higher thanthe upper surface of the outwardly extending portion 50 extending at anangle from the central body 30. The upper surface of the outwardlyextending portion 50 is higher than the upper surface of the laterallyextending wing 40 b through which it extends. Thus, one or both of eachof the scalloped cutout 274 and the lower right surface 272 b of thecentral body may serve as abutment surfaces which may restrict rotationof the medical article 20 about its longitudinal axis 22.

In an embodiment in which the height of the scalloped cutout 274 issubstantially identical to the height differential between the outwardlyextending portion 50 of the medical article and the laterally extendingwing 40 b, each of the scalloped cutout and surface 272 b may contactportions of the medical article and serve as an abutment surface. In anembodiment where the height of the scalloped cutout 274 is greater thanthe height differential between the outwardly extending portion 50 andthe wing 40 b, contact between the portion 50 and the scalloped cutout274 will prevent the wing 40 b from contacting the central body of theretainer, and in an embodiment where the height of the scalloped cutout274 is less than the height differential, contact between the wing 40 band surface 272 b will prevent contact between the portion 50 and thescalloped cutout 274.

Similarly, the distal surface 276 b of the front right sidewall 248 andthe proximal surface 278 b of the downwardly extending portion 260 mayserve as abutment surfaces which inhibit the longitudinal translation ofthe medical article 20 relative to the retainer 120. The front rightsidewall 248 and the downwardly extending portion 260 allow the wing 40b of the medical article 20 to be positioned therebetween. If themedical article 20 is longitudinally translated within the retainer, thesides of wing 40 b may contact one of the surfaces 276 b or 278 b,preventing further longitudinal translation.

In FIG. 12, it can be seen that the left side of the retainer 120comprises similar abutment surfaces. Rotation of the device 20 aroundits longitudinal axis 22 will be inhibited by contact between the uppersurface of wing 40 a and the lower left surface 272 a of the centralbody 204 of retainer 120. Similarly, the distal surface 276 a of leftfront sidewall 246 and the proximal surface 278 a of left rear sidewall242 constrain lateral translation of the medical article 20 relative tothe retainer 120 by contact with the sides of wing 40 a.

FIG. 13 is a cross-section view of the retainer 120 taken along line13-13 in FIG. 7. It can be seen in FIG. 13 that the distal surface 276 aof the front left sidewall 246, the lower left surface 272 a of thecentral body 204, and the proximal surface 278 a of left rear sidewall242 cooperate to define an opening through which the laterally extendingwing 40 a of the medical article 20 may extend. These surfaces may serveas abutment surfaces as described above, depending on the specificdimensions of the medical article 20 relative to the retainer 120.

FIG. 14 is a cross-section view of the retainer 120 taken along line14-14 in FIG. 7. The distal surface 276 b of the front right sidewall248, the lower left surface 272 b of the central body 204, the scallopedcutout 274, and proximal surface 278 b of the downwardly extendingportion 260 cooperate to define an opening through which the laterallyextending wing 40 b of the medical article may extend, along with theupper projection of the outwardly extending portion 50 extending abovethe upper surface of wing 40 b. These may also serve as abutmentsurfaces as described above. In particular, the upper surface ofscalloped cutout 274 may further inhibit upward translation of themedical article 20 or rotation about the longitudinal axis of themedical article 20, while the proximal and distal edges may furtherinhibit longitudinal translation of the article relative to the retainer120.

FIG. 15 is a perspective view of the securement device of FIG. 3 withthe medical article of FIG. 2 retained therein. The positioning of theretainer within the medical article can be seen in greater detail thanin FIG. 1, including the alignment of outwardly extending portion 50 andoutwardly extending wings 40 a and 40 b relative to the retainer 120.

FIG. 16 is a top plan view of the retainer 120 with the medical article20 retained therein. It can be seen that the interior edges of theanchor pads 110, 112, particularly triangular cutouts 122 a and 122 b,cooperate with the shapes of footings 210, 212, 214, and 216 to defineapertures on either side of the longitudinal axis of the retainer 120which allow the laterally extending wings 40 a and 40 b of the to passupwardly therethrough. In the illustrated embodiment, the distal edges280 a and 280 b of front footings 210 and 212 are shaped to match theproximal edge of triangular cutouts 122 a and 122 b. Similarly, theproximal edges 282 a and 282 b of rear footings 214 and 216 are shapedto match the distal edge of triangular cutouts 122 a and 122 b.

FIG. 17 is a side cross-section of the retainer 120 with the medicaldevice secured therein, taken along the longitudinal axis of theretainer 120. It can be seen in FIG. 17 that the medical article 20 issecured within the retainer 120 such that the longitudinal axis 22 ofthe medical article is aligned with the longitudinal axis of theretainer, each of which are preferably inclined at an angle to theunderlying skin of the patient. A variety of different angles can beused, ranging from 0° to 45°, and more preferably from 5° to 25°. Forinstance, for the securement of intravenous catheters, it is desirablefor the angle of incidence of the catheter to the skin of the patient tobe between about 7° to about 15°. For the securement of arterialcatheters, it is desirable for the angle of incident of the catheter tothe skin of the patient to be about 12.5°. It can also be seen in FIG.17 that the lower surface 24 of the retained medical article 20 will bespaced apart from the skin of the patient, such that the article itselfdoes not come into contact with the skin of the patient.

In one embodiment, use of the securement device may proceed as follows.A proximal portion of a medical article 20 may be inserted into apatient, and a caregiver aligns the central body 30 with the securementdevice 100, which includes the anchor pads 110 and 112 and the retainer120. The securement device 100 is oriented such that the proximalportion 206 and proximal abutment surface 226 overlie the frontsubstantially cylindrical portion 32 of the medical article 20, and thedistal portion 208 and distal abutment surface 228 overlie the backsubstantially cylindrical portion 36 of the medical article 20. Theaperture 224 in the central portion 204 of the retainer 120 may serve asa viewport and facilitate this alignment.

The medical article 20 is then brought upwards between the anchor pads110 and 112 such that the laterally extending wings 40 a and 40 b passthrough the cutouts 122 a and 122 b on their interior edges. Upwardpressure on the medical article 20 and the inwardly extending portionscauses a slight outward deformation of the retainer, allowing theproximal and distal substantially cylindrical portions of the medicalarticle to be pressed into and form a snap-fit configuration with thecorresponding abutment surfaces.

In alternate embodiments, a medical article such as medical article 20can be secured via a securement device having an upwardly openingchannel, such that the bulk of the retainer is located between themedical article 20 and the skin of the patient when the medical articleis retained therein. FIG. 18 illustrates such an embodiment of asecurement system 300, in which a medical article 20 is secured within aretainer 320 disposed on a single anchor pad 310 which may be adhered tothe skin 10 of a patient in a similar fashion as that illustrated inFIG. 1. It can be seen in FIG. 18 that the proximal substantiallycylindrical section 32 and the distal substantially cylindrical section36 of the medical article 20 are retained between opposing pairs ofupwardly extending members in order to inhibit at least lateral motionof the medical article 20 relative to the retainer 320.

FIGS. 19-27 illustrate various views of the retainer 320 and anchor pad310. In FIG. 19, it can be seen that a proximal or front abutmentsurface 322 is defined by a substantially semicylindrical channel 326located between a front left retention member 330 a and a front rightretention member 330 b. Similarly, a distal or rear abutment surface 324is defined by a substantially semicylindrical channel 328 locatedbetween a back left retention member 330 c and a back right retentionmember 330 d.

FIG. 20 is a perspective view of the anchor pad 310. In contrast to theanchor pads 110 and 112 of the previous embodiment, only a single anchorpad 310 is utilized in the illustrated embodiment of securement system300. As the medical article 20 can be inserted into the retainer 320from above, the securement system 300 does not require an aperture inthe anchor pads through which the medical article is inserted. Theanchor pad 310 may have a generally trapezoidal shape, and may besymmetrical about a longitudinal axis of the securement system 300,narrowing in the proximal direction. As can be seen in FIGS. 18 and 19,the anchor pad 310 may have a footprint which extends beyond not onlythe footprint of the retainer 320, but also beyond the edges of thelaterally extending wings 40 a and 40 b of the medical article whenretained within the securement system 300. A wide variety of othershapes and sizes of anchor pads may also be suitable for use with such asecurement system.

The anchor pad 310 may be similar in other respects to the anchor pads110 and 112 of the previous embodiment. The anchor pad 310 comprises aremovable liner 316 in contact with the lower surface 314 of the anchorpad, with pull tabs 318 to facilitate removal of the anchor pad. Theanchor pad 310 further comprises an upper surface 312 to which theretainer 320 can be secured.

As can most clearly be seen in FIGS. 22 and 23, the retention members330 a-330 d comprise inwardly extending lips 334 a-334 d, such that theabutment surfaces 322 and 324 include the lower surfaces of theseinwardly extending lips 334 a-334 d and the abutment surfaces 322 and324 therefore extend slightly more than 180° around a longitudinal axisof the retainer 320. The retention members 330 a-330 d may comprise aresilient material or a resilient thickness of material such that someoutward deformation of the retention members 330 a-330 d is possible.The inwardly extending lips of each pair of retention members may bespaced apart from one another by a distance which is slightly less thanthe diameter of the portion of the medical article to be retained bythat pair of retention members, such that the retention members may bedeformed outward to allow passage of the medical article 20 into thechannels 326 and 328. Once the medical article is in contact withsubstantially the entire abutment surfaces 322 and 324, the pairs ofretention members may move back towards one another, such that theinwardly extending lips may inhibit transverse motion of the medicaldirection. The outward deformation of the retention members 330 a-330 dto allow passage of the medical article 20 thereby may be facilitated bychamfered contact surfaces 332 located on the upper interior portions ofthe retention members 330 a-330 d.

With respect to FIGS. 19 and 21, it can be seen that the proximal end ofthe retainer 320 includes raised portions 340 a and 340 b, which extendupward to a height which is less than the maximum height of theretention members 330 a and 330 b. The raised portions 340 a and 340 bfurther comprise substantially coplanar upper surfaces 342 a and 342 b,as well as distal faces 344 a and 344 b. The distal faces 344 a and 344b may extend either outward in a lateral direction, or may extend at aslight distal angle corresponding to the angle of the proximal edges ofthe laterally extending wings 40 a and 40 b of medical article 20. Thesedistal faces may prevent longitudinal motion of a retained medicalarticle in a proximal direction relative to the retainer 320, as theforward edges of the wings 40 a and 40 b will abut the distal faces 344a and 344 b during such movement.

In certain embodiments, the upper surfaces 342 a and 342 b may rise to aheight which is substantially equal to that of the upper surface of thelaterally extending wings 40 a and 40 b of the medical article 20 whenthe medical article is secured within the retainer. By avoiding asignificant disparity in the height of the front edge of the laterallyextending wings and the raised portions 340 a and 340 b, no edge isprovided on which another object could catch and cause dislodgement ofthe medical article or other distress to the securement device orinsertion site. In further embodiments, the upper surfaces 342 a and 342b may be oriented at a slight angle, equal to the incline of thelongitudinal axis 302 of the retainer 320, such that the upper surfaceof the wings 40 a and 40 b and the upper surfaces 342 a and 342 b may besubstantially coplanar. In other embodiments, however, the uppersurfaces 342 a and 342 b may rise to a height which is greater or lessthan the height of the front edge of the wings 40 a and 40 b.

As can be seen in FIGS. 19 and 21, the distal end of the retainer 320includes raised left rear portion 360 a and raised right rear portion360 b. In contrast to the raised front portions 340 a and 340 b, theraised rear portions 360 a and 360 b are not symmetrical. The raisedleft portion 360 a, which will be located on the opposite side of themedical article 20 from the outwardly extending portion 50 and tubing 52of the medical article 20, includes a proximal face 366 which is shapedto be substantially complimentary to that of the left laterallyextending wing, including a curved interior section and located closerto the longitudinal axis 302 of the retainer 320 than a linearlyextending outer section which extends at an angle substantiallycorresponding to the angle of the rear edge of the linearly extendingwing. In contrast, the proximal face 368 of the raised right rearportion 360 b extends laterally outward without extending longitudinallyforward, so as to allow passage thereby of the outwardly extendingmember 50 and associated tubing 52 of the medical article 20 withoutinterference.

A base 350 of the retainer 320 extends generally between the raisedportions located at the proximal and distal ends of the retainer. Uppersurfaces 352 a, 352 b, and 352 c of the base are generally coplanar andoriented parallel to the longitudinal axis 302 of the retainer 320. Alongitudinally extending central channel 354 runs through the center ofthe base, and is dimensioned to allow the central body 30 of the medicalarticle to be retained therein. In certain embodiments, a generallyelliptical aperture 355 located at the base of the channel 354 may allowa portion of a retained medical article to come into contact with theunderlying anchor pad 310. A side channel 356 extends outward from thecentral channel 354 and is oriented at an angle to the longitudinal axis302 of the retainer 320 which corresponds to the angle of the outwardlyextending member 50 of the medical article 20. The depth of the sidechannel 356 may be less than the depth of the central channel 354, giventhe relative thicknesses of the central body 30 and the outwardlyextending member 50 of the medical article 20.

Thus, in certain embodiments, some or all of the planar upper surfaces352 a-352 c, the channel 356, and the channel 354 may serve as abutmentsurfaces to constrain movement of the medical article 20. In particular,the planar surfaces 352 a-352 c may prevent rotation of the medicalarticle about the longitudinal axis, as rotation of the article maybring the lower surfaces of wings 40 a or 40 b into contact with planarsurfaces 352 a-352 c. If the depth of side channel 356 is substantiallyequal to or less than the height differential between the base of thewing 40 b and the base of the outwardly extending member 50 extendingtherethrough, the base of channel 356 may also serve as an abutmentsurface to prevent rotation. Similarly, any of surfaces 352 a-352 c, thechannel 356, and the channel 354 may serve as an abutment surface toinhibit excessive downward flexure of portions of the medical article20.

Operation of the securement device 300 may proceed as follows: A liner316 may be removed to expose the lower surface 314 of an anchor pad 310,and the anchor pad 310, with a retainer 320 fixed thereon, may beadhered to the skin of a patient. A medical article 20 may be positionedover the retainer 320 such that a substantially cylindrical frontsection 32 overlies a proximal abutment surface 322 and a substantiallycylindrical back section 36 overlies a distal abutment surface 324. Themedical article is then pressed downward, and the interaction betweenthe curved underside of the substantially cylindrical sections causesthe front pair of retention members 330 a and 330 b and the back pair ofretention members 330 c and 330 d to deform slightly outward in alateral direction from the other retention member in the pair, allowingthe substantially cylindrical sections to be brought into contact withthe proximal and distal abutment surfaces. The retention members thenflex back inward so as to slightly overlie portions of the medicalarticle to prevent transverse movement of the medical article relativeto the retainer. Further movement of the medical article is inhibited bythe various abutment surfaces as described above.

FIG. 24 is a right side view of the retainer of the securement devicetaken along line 24-24 in FIG. 21 without the anchor pad. FIG. 25 is aright side view of the retainer of the securement device taken alongline 25-25 in FIG. 21 without the anchor pad. In FIGS. 24 and 25, theangles of upper surfaces 352 a and 352 b of the base are visible. It canalso be seen that in the illustrated embodiment, the surfaces 342 a, 342b, 360 a and 360 b are substantially parallel to and transversely offsetfrom surface 352 b. This configuration enables the upper surfaces ofwings 40 a and 40 b of the medical article to lie substantially parallelto and aligned with the surfaces 342 a, 342 b, 360 a and 360 b inparticular embodiments.

FIG. 26 is a cross-section view of the retainer taken along line 26-26in FIG. 21 without the anchor pad. FIG. 27 is a cross-section view ofthe retainer taken along line 27-27 in FIG. 21 without the anchor pad.In FIGS. 26 and 27, it can be seen that the upper surfaces 352 a and 352b of the base are substantially parallel to the longitudinal axis 302 ofthe retainer.

FIG. 28 is an exploded assembly view of the securement device andmedical article of FIG. 18. It can be seen in FIG. 28 that the sidechannel 356 may provide both tactile and visual guidance to a caregiverregarding the desired longitudinal position of the medical article 20relative to the retainer. The proximal face 366 of the raised leftportion 360 a and the distal faces 344 a and 344 b of the front raisedportions 340 a and 340 b may also provide such guidance.

FIG. 29 is a top plan view of the retainer 320 with the medical article20 retained therein. It can be seen that the distal edges 344 a and 344b of raised proximal portions 340 a and 340 b along with proximal edge366 of raised distal portion 360 a cooperate to define a receiving spacewhich is substantially complimentary to the footprint of the medicalarticle 20, and in particular to the shape of the laterally extendingwings 40 a and 40 b.

FIG. 30 is a side cross-section of the retainer 320 with the medicaldevice 20 secured therein, taken along the longitudinal axis of theretainer 320. It can be seen in FIG. 30 that the medical article 20 issecured within the retainer 320 such that the longitudinal axis 22 ofthe medical article is aligned with the longitudinal axis of theretainer 320, each of which are preferably inclined at an angle to theunderlying skin of the patient. As noted above with respect to theprevious embodiment, a variety of different angles can be used, rangingfrom 0° to 45°, and more preferably from 5° to 25°

FIG. 31 illustrates another embodiment of a securement device 400, whichcomprises a retainer 420 disposed on an anchor pad 410. FIG. 31 is aperspective view of the retainer 420 and the anchor pad 410. FIG. 32 isa top plan view of the securement device 400 and retained medicalarticle 20 of FIG. 31.

FIGS. 33-38 illustrate various views of the retainer 420 and anchor pad410. FIG. 35 is a perspective view of the anchor pad 410 of thesecurement device 400 of FIG. 31. The anchor pad 410 may be similar insize and structure to the anchor pad 310 of FIG. 20, and may include aremovable liner 416 covering the bottom surface 414 of the anchor pad410. The removable liner may comprise pull tabs 418 to facilitateremoval of the liner 416. The upper surface 412 of the anchor pad 410may be roughened or otherwise altered to facilitate fixation of theretainer 420 to the upper surface 412 of the anchor pad 410.

In FIG. 34, it can be seen that the retainer 420 comprises an angledbase 430 in the proximal section of the retainer, having substantiallycoplanar upper surfaces 432 a, 432 b, and 432 c. As discussed withrespect to securement structure 300, these upper surfaces may beoriented at an angle substantially parallel to the angle of thelongitudinal axis 402 of retainer 420, and this angle may vary based onthe intended use of the medical article 20 to be retained. As discussedabove, a variety of different angles can be used, ranging from 0° to45°, and more preferably from 5° to 25°

A longitudinally extending channel 440 extends longitudinally along thebase from the proximal edge of the retainer to a point at or close tothe retention structure 450 at the distal end of the retainer. Thechannel 440 may include an aperture 442 at the base of the channel 440if the desired depth of the channel is greater than the thickness of thebase 430 at any point along the base of the channel 440. A side channel444 extends from the longitudinally extending channel 440 to the rightedge of the retainer 440, at an angle which is substantially equal tothe angle at which the outwardly extending member 50 of the medicalarticle extends. In the illustrated embodiment, the height differentialbetween the base of the angled side channel 444 and the planar uppersurfaces 432 b and 432 c of base 430 is substantially equal to theheight differential between the base of the outwardly extending member50 and the laterally extending wing 40 b through which it extends.

The retention structure 450 comprises a channel 422 which issubstantially cylindrical in shape and is centered along thelongitudinal axis 402 of the retainer. The proximal end of the channel422 is defined by a cylindrical portion extending about the longitudinalaxis 402 of the retainer. The proximal interior edge 451 of thecylindrical portion 452 may be rounded or chamfered to facilitateinsertion of the distal end of the medical article therein, as discussedin greater detail below.

Distal of the cylindrical portion 452, a pair of radial cuts 457 a and457 b extend from points near the uppermost portion of the channelthrough almost a 90° arc, and ending near the midpoint of the channel. Apair of longitudinal cuts 458 a and 458 b extend in a distal directionfrom the lower ends of the radial cuts 457 a and 457 b and run to theproximal edge of the retention structure 450. These cuts separate anupper portion of the material defining the cylindrical channel 422 fromthe underlying material to form a rounded flap 456, and the portion ofthe retention structure 450 located between the upper ends of the radialcuts 457 a and 457 b serves as a connector 454 between the flap 456 andthe fixed cylindrical portion 452. The thickness and/or width of thematerial forming the connector 454 allows resilient deformation of theflap 456 in an upwards or downwards rotation about the connector 454while biasing the flap to return to the position illustrated in FIGS.33, 34, and 36-38. In alternate embodiments, as discussed above, theflap 456 may be biased to return to a position in which the flap 456 isbent slightly downward towards the underlying base of channel 422.

Tapered footings 460 a and 460 b are located on either side of theretention structure. Each of tapered footings 460 a and 460 b have ancurved upper surface 466 which tapers generally upward to the retentionstructure 450 and to the longitudinally extending cuts 458 a and 458 btherein to facilitate grasping of the flap 456 by a caregiver. The lefttapered footing 460 a has a proximal face 462 which extends away fromthe central channel 422 and towards the proximal edge of the retainer420. The outer portion of the proximal face 462 of tapered footing 460 aextends at an angle corresponding to the angle of the distal edge ofwing 40 a of the medical device 20. This proximal face 462 can thusserve as an abutment surface to interact with wing 40 a to inhibitmovement of a retained medical article 20 in a distal direction relativeto the retainer 420. The right tapered footing 460 b has a proximal face464 which extends laterally outward and longitudinally rearward at anangle which corresponds to the angle at which the outwardly extendingmember 50 of the medical device 20 extends, so as to allow passage ofthe outwardly extending member 50 thereby when the medical article 20 issecured within the retainer 420. The right tapered footing 460 b alsoincludes an interior proximal face 465 which may serve as an abutmentsurface to interact with the innermost part of the distal edge of wing40 b.

FIG. 36 is a front view of the retainer taken along line 36-36 in FIG.33 without the anchor pad. FIG. 37 is a back view of the retainer takenalong line 37-37 in FIG. 33 without the anchor pad. It can be seen inFIGS. 36 and 37 that the central channel 422 is substantiallycylindrical and canted downward in a proximal direction. It can also beseen in FIG. 37 that the channel includes an inwardly extending tang 470extending transversely downwards from the flap 456, which is discussedin greater detail below.

FIG. 38 is a side view of the retainer taken along line 38-38 in FIG. 33without the anchor pad. FIG. 39 is a side view of the retainer takenalong line 39-39 in FIG. 33 without the anchor pad. As can be seen inFIGS. 38 and 39, the longitudinally extending cuts 458 a and 458 bextend in a direction substantially orthogonal to a plane defined by theradial cuts 457 a and 457 b. In certain embodiments, however, the flapmay be biased slightly downward, and the lower surface of flap 456 maycontact with underlying surface at the distal end of the retainer whenno medical article is retained therein. It can also be seen in FIGS. 38and 39 that the upper surfaces 432 a and 432 c of base 430 slopedownward in a proximal direction and are oriented at an anglesubstantially parallel to that of the longitudinal axis 402 of theretainer.

As can best be seen in FIGS. 40-41, the inner surface of flap 456 facingchannel 422 may comprise at least one inwardly extending tang 470configured to interact with an corresponding surface on the medicalarticle to be retained, as will be discussed in greater detail below.Tang 470 has an asymmetrical shape to facilitate insertion and retentionof medical articles such as medical article 20. In particular, it can beseen that the proximal face 472 of tang 470 is oriented at an anglewhich is substantially less than 90° to the interior surface 424 ofchannel 422. This shallow angle facilitates the insertion of the medicalarticle 20 into the channel 422 from the proximal side of the channel,allowing the medical article 20 to be translated distally along thechannel in a longitudinal direction without catching on the proximalface 472 of tang 470. The distal face 474 of tang 470 forms an anglewhich is close to or equal to 90° with the interior surface 424 ofchannel 422. This angle allows the distal face 474 of tang 470 to catchon a corresponding surface of the medical article to inhibitlongitudinal movement of the medical article 20 in a proximal directionalong the channel 422.

Operation of the securement system 400 is now described with respect toFIGS. 42-44. In certain embodiments, the tip 34 of medical article 20may be inserted into the skin of the patient prior to securement of themedical article 20 within the securement device 400. The securementsystem 400, including the anchor pad 410 and the retainer 420, isaligned with the medical article 20 such that the distal end 36 of themedical article 20 is aligned with the proximal end of channel 422. Thedistal end 36 of the medical article 20 is then inserted into thechannel 422 and translated longitudinally in a distal direction. Thedistal edge 480 of the medical article will initially contact theproximal face 472 of tang 470, which extends downwardly into the channel422. Because the proximal face 472 is canted in a distal direction,pressure of the distal edge 480 on the proximal face 472 of tang 470will cause the flap 456 to bend upward, away from the medical article,allowing passage of a portion of the medical article 20 through channel422 past the tang 470.

As can be seen in FIG. 42, the connection means 38 of the medicalarticle 20 comprise a depression, grove, or recess 482 extendingradially inward and almost 180° about the upper surface of medicalarticle 20. As can be seen in FIG. 43, the depression 482 has alongitudinal width which is greater than the longitudinal width of tang470, and a depth which is greater to or substantially equal to theheight of tang 470, such that when the medical article 20 islongitudinally translated such that the distal face 486 passes thedistal face 474 of tang 470, the biased flap 456 can move downwardagainst the upper surface of medical article 20 and the tang 470 canrest within depression 482 without the proximal face 472 of tang 470contacting the proximal face 484 of depression 482. Longitudinaltranslation of the medical article 20 may continue until the distaledges of wings 40 a and 40 b of medical article 20 abut the proximalface 462 of footing 460 a and the interior proximal face 465 of footing460 b, respectively.

Longitudinal translation of the medical article 20 in the distaldirection is thus inhibited at least by abutment of the distal edges ofthe longitudinally extending wings 40 a and 40 b with proximal surfaces462 and 465 of footings 460 a and 460 b. Longitudinal translation of themedical article 20 in the proximal direction will be inhibited by theabutment of distal face 474 of tang 470 against the distal face 486 ofdepression 482 in medical article 20, so long as the tang 470 is locatedwithin the depression. In contrast to proximal edge 472 of tang 470,which is canted to prevent the proximal edge from inhibiting movement ofthe medical article, the distal edge 474 is oriented at a substantiallyright angle to the interior surface 424 of channel 422, and will thusprevent movement of the medical article 20 in the proximal direction. Inthe illustrated embodiment, the tang 470 is located at a position alongthe length of the channel 422 such that longitudinal play of the medicalarticle is reduced or substantially eliminated, to prevent the article20 from sliding back and forth before contacting an abutment surface.

Transverse motion of the medical article 20 can be inhibited by theupper surface of channel 422, and in particular by cylindrical portion452 of the retention structure 450. Rotation and lateral translation ofthe medical article can be inhibited by the sides of channel 422 as wellas by the abutment of wings 40 a and 40 b against faces 462 and 465 offootings 460 a and 460 b.

As illustrated in FIG. 44, lifting of the flap 456 by a caregiverpermits withdrawal of the medical device 20 from the channel 422, as thedistal face 474 of tang 470 no longer abuts the distal face 486 ofdepression 482 in medical article 20. The caregiver may then grasp thedistal edges of wings 40 a and 40 b to translate the medical article ina proximal direction and withdraw the medical article 20 from channel422. Lifting of the flap 456 may be facilitated by the overhang of flap456 in the distal direction beyond the distal end of the base of channel422, or alternately by the sloped upper surface of footings 460 a and460 b leading to the longitudinally extending grooves 458 a and 458 b.

The various embodiments of securement devices and techniques describedabove thus provide a number of ways to provide safe and releasablesecurement for medical articles to the skin of a patient. In addition,the techniques described may be broadly applied for use with a varietyof medical lines and medical procedures.

Of course, it is to be understood that not necessarily all suchobjectives or advantages may be achieved in accordance with anyparticular embodiment using the systems described herein. Thus, forexample, those skilled in the art will recognize that the systems may bedeveloped in a manner that achieves or optimizes one advantage or groupof advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. Although thesetechniques and systems have been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that these techniques and systems may be extended beyond thespecifically disclosed embodiments to other embodiments and/or uses andobvious modifications and equivalents thereof. Additionally, it iscontemplated that various aspects and features of the inventiondescribed can be practiced separately, combined together, or substitutedfor one another, and that a variety of combination and subcombinationsof the features and aspects can be made and still fall within the scopeof the invention. Thus, it is intended that the scope of the systemsdisclosed herein disclosed should not be limited by the particulardisclosed embodiments described above.

What is claimed is:
 1. A securement device for securing a medicalarticle, the securement device comprising: first and second anchor pads,each comprising an upper foam layer and a lower adhesive surface, thelower adhesive surface being configured to attach to an epidermal layerof a patient; and a retainer comprising, a body member having aninverted channel formed therethrough, the inverted channel beingconfigured to retain a portion of the medical article and having alongitudinal access opening disposed on an underside of the body memberto allow ingress and egress of the portion of the medical article, firstand second anchor pads underlying the body member and laterally offsetin opposite directions from the longitudinal access opening, first andsecond proximal members extending generally transversely downward fromthe body member and defining a proximal retention surface therebetween,wherein the first proximal member terminates in a first proximal footingwhich is secured to the first anchor pad and the second proximal memberterminates in a second proximal footing secured to the second anchorpad, first and second distal members extending generally transverselydownward from the body member and defining a distal retention surfacetherebetween, wherein the first proximal member terminates in a firstdistal footing which is secured to the first anchor pad, and wherein thesecond proximal member terminates in a free end unsecured to an anchorpad, and an offset member extending laterally outward and longitudinallyproximal from a point on the body member, the offset member having adownwardly extending portion at its outer end, the downwardly extendingportion terminating in a second distal footing which is secured to thefirst anchor pad.
 2. The securement device of claim 1, wherein theproximal edges of said first and second distal members comprise abutmentsurfaces configured to inhibit longitudinal translation of a medicalarticle secured within the channel.
 3. The securement device of claim 1,wherein the distal edges of said first and second proximal memberscomprise abutment surfaces configured to inhibit longitudinaltranslation of a medical article secured within the channel.
 4. Thesecurement device of claim 1, wherein the body comprises a scallopedcutout on a lower edge of the body member between the second proximalmember and the second distal member.
 5. The securement device of claim1, wherein the first and second anchor pads comprise interior surfacesshaped so as to allow ingress and egress of the portion of the medicalarticle therebetween.
 6. The securement device of claim 5, wherein theinterior surfaces of the first and second anchor pads comprisetriangular cutouts configured to permit laterally extending wings of amedical article to pass therethrough.
 7. A system for securing a medicalarticle, the system comprising: a retainer, the retainer comprising: aproximal pair of upwardly extending members defining a proximalretention surface therebetween; first and second raised proximalportions extending along a proximal edge of the retainer, a distal pairof upwardly extending members defining a distal retention surfacetherebetween; first and second raised distal portions extending along adistal edge; and a medical article, the medical article comprising: alongitudinally extending central body; a pair of laterally extendingwings extending outward from the central body; and an outwardlyextending member extending laterally outward and longitudinally distalfrom the central body, at least a portion of the central body beingretained by the proximal and distal retention surfaces of the retainer.8. The system of claim 7, wherein the first and second raised proximalportions comprise distal faces which extend at angles relative to alongitudinal axis of the retainer which match the angles at which theproximal edges of the laterally extending wings relative to alongitudinal axis of the medical article.
 9. The system of claim 7,wherein the first raised distal portion comprises a proximal face whichextends at an angle relative to a longitudinal axis of the retainerwhich matches an angle at which the distal edge of a laterally extendingwing extends relative to a longitudinal axis of the medical article. 10.The system of claim 7, wherein the second raised distal portioncomprises a proximal face which extends at an angle relative to alongitudinal axis of the retainer which matches an angle at which theoutwardly extending member of the medical article extends relative to alongitudinal axis of the medical article.
 11. The system of claim 7,wherein the first and second raised distal portions extend to a heightwhich is substantially equal to the height of the front edges of thelaterally extending wings.
 12. A retainer for securing a medicalarticle, the retainer comprising: a base having an upper surface tiltedat a downward angle in a proximal direction, the base comprising alongitudinally extending depression formed therein; and a retentionstructure, the retention structure comprising a substantiallycylindrical channel extending between proximal and distal ends, a firstportion of the channel being movable in a generally transverse directionrelative to a second portion of the channel.
 13. The retainer of claim12, wherein the first portion and the second portion simultaneouslysecure portions of a retained medical article.
 14. The retainer of claim12 further comprising a tang, the tang extending radially inward andbeing configured to engage with a retained medical article so as toinhibit longitudinal motion of said medical article in a proximaldirection.
 15. The retainer of claim 14, wherein the tang comprises aproximal face which is canted in a distal direction, and a distal facewhich extends radially inward and at a substantially right angle fromsaid first portion.
 16. The retainer of claim 12 further comprisingfirst and second footings located on opposite sides of the retentionstructure.
 17. The retainer of claim 16, wherein the first footingcomprises a proximal face extending laterally outward and longitudinallyproximal of the proximal end of the retention structure, and wherein thesecond footing comprises a proximal face extending laterally outward andlongitudinally distal of the proximal end of the retention structure.18. The retainer of claim 12 further comprising a connecting portionabout which the first portion pivots relative to the second portion,wherein the first portion of the retainer comprises a flap defined by apair of radially extending grooves extending downward from oppositesides of the connecting portion, and a pair of longitudinally extendinggrooves extending between the lower end of the radially extendinggrooves and the distal end of the retention structure.
 19. A securementdevice for receiving a medical article having an elongated body, a pairof wings, and a side lumen, the side lumen extending through at least aportion of one of the pair of wings, the securement device comprising: abody member having a first pair of footings, a second pair of footings,and an arm member, each of the first and second pairs of footingsdefining a retention surface for receiving a portion of the elongatedbody of the medical article therebetween, at least one of the first pairof footings and at least one of the second pair of footings defining aside opening in the body member, the side opening receiving at least aportion of one of the pair of wings and at least a portion of the sidelumen when the medical article is secured within the body member, thearm member defining a side channel at least partially aligned with theside opening, the side channel receiving at least a portion of the sidelumen when the medical article is secured within the body member; and atleast one anchor pad supporting the body member.
 20. The securementdevice of claim 19 further comprising a second side opening in the bodymember, the second side opening receiving at least a portion of theother one of the pair of wings.